FDA.reportPublic FDA data

FLUOCINOLONE ACETONIDE

Product NDC
68462-590
11-digit product format
684620590
Labeler code
68462
Product ID
68462-590_49e4ce6d-f8e8-48f5-90e5-ad7b43170026
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210539
Marketing category
ANDA
Marketing start
2018-10-30
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLUOCINOLONE ACETONIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-590-89FLUOCINOLONE ACETONIDE1 in 1 CARTONOIL13
68462-590-89FLUOCINOLONE ACETONIDE118.28 mL in 1 BOTTLEOIL118.283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-590-89ML - Milliliter68462-590e37c513b-4080-41b4-b1bd-01f8339109f512019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-590FLUOCINOLONE ACETONIDE OIL [GLENMARK PHARMACEUTICALS INC., USA]3Current NDC, Legacy NDC, 2 package rows20240103_47de7132-c692-4c77-8160-ab0c1f501a7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191307fluocinolone acetonide 0.01 % Topical OilPSN47de7132-c692-4c77-8160-ab0c1f501a7c3
1191307fluocinolone acetonide 0.1 MG/ML Topical OilSCD47de7132-c692-4c77-8160-ab0c1f501a7c3
1191307fluocinolone acetonide 0.01 % Topical OilSY47de7132-c692-4c77-8160-ab0c1f501a7c3
1191307fluocinolone acetonide 0.011 % Topical OilSY47de7132-c692-4c77-8160-ab0c1f501a7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-590-89684620590891 BOTTLE in 1 CARTON (68462-590-89) / 118.28 mL in 1 BOTTLE1 bottle2018-10-300000-00-00NoNoCurrent